Search results for "manufacturing" in Articles / App Notes
Article
Sterilization Trends for Single-Use Consumables
As the biopharmaceutical market continues to expand and reliance on single-use manufacturing rises, demand for SU consumables—bags, containers, filters, tubing, etc.—is also increasing. The value of t…
Article
Digitalization: The Route to Biopharma 4.0
It is evident that there is an urgent need to incorporate digital solutions at initial stages of process development, manufacturing, and quality assurance (QA).
Digitalization in pr…
Article
The Outlook for CMO Outsourcing in 2019
Rader
Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial API and biopharmaceutical product ma…
Article
Evaluating E&L Studies for Single-Use Systems
for manufacturing processes, in addition to multi-use (MU) materials (i.e., glass bottles, stainless steel tanks, etc.) (1). Regulatory guidelines require that the product contact items “shall not be …
Article
Advancing Single-Use Technology Through Collaboration
By Cheryl Zigrand
The use of disposable, single-use components within the biopharmaceutical manufacturing process is not a new phenomenon. Silicone tubing, capsule filters, tissue culture flasks, …
Article
Perfusion in the 21st Century
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufacturing has steadily advanced over the past three decades. Batch processing, in which all raw materials are introduce…
Article
The Lifecycle Change of Process Validation and Analytical Testing
I think material understanding throughout the manufacturing process from the product development phase onwards will not only support a robust commercial manufacturing process but can also reduce the b…
Article
Setting Up Bioprocessing Systems for Digital Transformation
By Feliza Mirasol
The advancement of digitalization technologies is transforming manufacturing processes and operations in the biopharmaceutical industry. Bioprocessing is no exception, as the ind…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
… online), enabling automated and continuous process control—sometimes thought of as “lights out manufacturing.” The enabling real-time analytical solutions may be based on established and validated t…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
…therapies progressing toward regulatory review, there is increased focus on establishing commercial manufacturing facilities for these complex biotherapeutics. The workflows of a cell therapy or a ge…